Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Pregnant Women

BioNet-Asia Co., Ltd.

Status: Enrolling

Conditions: Pertussis (whooping Cough); Pertussis Vaccines

Study type: Observational

Funder types: Industry

Identifiers

NCT06888076

PerMIS-01

Details and patient eligibility

About

This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen®.

Following approval of the final protocol from the Institutional Review Board (IRB) and/or Ethics Committee (EC) and written approval from hospital directors/medical doctors as per requirements of each institutions. The assigned Ob-gyn specialist/physician at each study site will review the medical record of pregnant women (January 2020 to April 2024) based on study selection criteria. Safety information of pregnant women who received Pertagen® and have given birth from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® will be obtained from medical records in hospitals/clinics and will be reported in case report form (CRF) by assigned Ob-gyn specialist/physician at each study site. The assigned Ob-gyn specialist/physician at each study site who will review the medical records and report the data in case report form (CRF) is not part of the research team.

Full description

A CRF has been developed and will be used to collect safety information on pregnancy outcomes including the health status of infants at birth. The following definitions will be used for data collection

• The 2nd trimester of pregnancy is defined as gestational period between 13-26 weeks
• The 3rd trimester of pregnancy is defined as gestational period from 27 weeks to delivery.
• Full term birth is defined as delivery of a baby at gestational age (GA) ≥37 weeks.
• Preterm birth is defined as delivery of a baby at GA<37 weeks.
• Complications during delivery may include postpartum hemorrhage, maternal fever or infection, or any maternal and fetal indications that may require emergency caesarean section.
• Safety information of pregnancy and delivery outcome refers to health of women during pregnancy and childbirth (WHO 2024). The most common direct causes of maternal injury and death are excessive blood loss, infection, high blood pressure, unsafe abortion, and obstructed labor, as well as indirect causes such as anemia and heart disease (WHO 2024).
• A newborn is defined as healthy at birth if discharged from the hospital in the first few days of life.
• A newborn is defined as not healthy if with difficulty of breathing, congenital abnormality or other conditions that would require prolonged stay at the hospital.

To ensure the privacy and confidentiality of the collected data, strict adherence to all relevant data protection regulations will be followed.

Enrollment: 2,700 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Data of pregnant women previously vaccinated with Pertagen® during second or third trimester of pregnancy and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® during pregnancy.
2. Infant of pregnant women who received Pertagen® during second or third trimester of pregnancy

Exclusion criteria

1. pregnant women previously vaccinated with Pertagen®, but maternal and infant data at delivery/birth cannot be obtained.

Trial design

2,700 participants in 1 patient group

Pregnant women received Pertagen® and have given birth in Jan 2021-Apr 2024 and their infants

Description:

The pregnant women (previously vaccinated with Pertagen®) and have given birth in Thailand from Jan 2021 - Apr 2024 and infants born to pregnant women who received Pertagen®.